MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121732054
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that patient underwent revision surgery.A pinnacle liner has disassociated from the cup.The cup was not revised, but surgeon noted there was damage to the cup with the ceramic head articulating against it.Initial procedure was done a few weeks prior.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: surgeon called me today to ask if i could get revision heads for a revision, he is doing for a pinnacle liner which has disassociated from the cup.Revision heads as the corail stem is being retained.He said that it was only done a few weeks ago and they have (b)(4) in situ.It is going to be revised tomorrow [date].After investigating usage between the two hospitals which the primary surgeon works at (hospital) i have only been able to find recent usage for (b)(4) at (hospital) on [date].I'll try get the hospital to decontaminate the liner for return and investigation.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment screenshot (92).Png, (b)(4) image.The photographs do not represent the reported acetabular cup.However, based on the observed condition of the involved ceramic head and liner it is reasonable to conclude that a disassociation event occurred between the liner and the cup.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the acetabular cup failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may contributed.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.A manufacturing record evaluation was performed for the finished device product description: pinn sector w/gription 54mm product code: 121732054 lot number: m7328a and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed based on the observations of the involved implants (ceramic head an liner).The pinn sector w/gription 54mm would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device product description: pinn sector w/gription 54mm product code: 121732054 lot number: m7328a and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: pinn sector w/gription 54mm product code: 121732054 lot number: m7328a and no non-conformances or manufacturing irregularities were identified.

• Brand Name: PINN SECTOR W/GRIPTION 54MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22047663
• Report Number: 1818910-2025-08150
• Device Sequence Number: 9017711
• Product Code: KWA
• UDI-Device Identifier: 10603295010319
• UDI-Public: (01)10603295010319
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K093646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121732054
• Device Lot Number: M7328A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 12/14 32MM +5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown